FDA Adverse Event
Malfunction
Summary report: N
COAGUCHEK ® XS SYSTEM
MDR report key: 2972176
·
Received February 21, 2013
Report
- Report Number
- 1823260-2013-01106
- Event Type
- Malfunction
- Date Received
- February 21, 2013
- Date of Event
- January 23, 2013
- Report Date
- April 4, 2013
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- GJS
- PMA / PMN Number
- K062925
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.
Description of Event or Problem · 1
CALLER REPORTS THAT DURING A CORRELATION STUDY THE FOLLOWING COAGUCHEK XS/LABORATORY RESULTS WERE OBTAINED: 2.7 INR/2.0 INR. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 76757 | COAGUCHEK ® XS SYSTEM | PROTHROMBIN TIME TEST STRIPS | GJS | ROCHE DIAGNOSTICS | NA | 21610911 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 086 YR | METHOPROLOL TARTRATE 12.5 MG BID| NAMENDA 10 MG BID| ALBUTEROL SULFATE HFA 2 PUFFS EVERY 6 HOURS| ENLIVE 0.037 GRAM-1.04 KCAL/ML- 6.7 OUNCES DAILY| METHIMAZOLE 5 MG DAILY| PROSCAR 5 MG DAILY| GALANTAMINE HBR 24 MG DAILY| WARFARIN |